FDA-Device2021-03-03Class III
S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only.
Medline Industries Inc
Hazard
Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.
Sold states
US Nationwide distribution in the states of MS, OH, IL.
Affected count
46 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1135-2021Don't want to check this manually?
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